Senior pharmacovigilance practice
Isthmus gives clinical-stage biotechnology companies senior pharmacovigilance infrastructure, operations, inspection readiness, and strategic advisory—at the moment their safety model needs to change.
years of global pharmacovigilance leadership
DKMA and EU GVP inspection settings
from development through submission, launch, and post-marketing
The practice
An isthmus is a narrow passage. In drug development, pharmacovigilance is that passage: the operating system that turns clinical evidence into regulatory confidence.
BUILD
Before first patient in, the safety function needs a practical operating model—not a stack of documents that cannot run a trial.
STRENGTHEN
When a bundled CRO model is no longer enough, ownership must stay clear across vendors, systems, case volume, geography, and submission work.
ASSURE
Most safety findings are workflow failures, not knowledge failures. A robust system shows its evidence when compliance signals drift, reporting pressure rises, or an inspection begins.
What we do
Engagements draw from across the PV lifecycle. The composition follows where the sponsor is in development—not a fixed service menu.
How we engage
Each model has a defined scope, cadence, and a single point of senior accountability. Choose a sprint, embedded leadership, or operations that scale with the portfolio.
For pre-IND or first-trial biotechs that need a pharmacovigilance function operational by a defined milestone.
Outcome. A fully documented, audit-defensible PV function ready for first patient in.
For biotechs that need senior pharmacovigilance ownership without committing to a full-time hire.
Isthmus provides senior leadership across operating model, vendor governance, submissions compliance, safety systems, and inspection readiness. Operational execution and medical judgment remain connected, while the sponsor retains clear accountability and decision rights.
Outcome. Senior PV ownership matched to the sponsor’s stage, with specialist medical safety support where it creates value.
For biotechs with active trials that need dependable delivery without building and carrying an internal team.
The engagement starts with a team sized to current case volume and trial complexity, then scales as the portfolio evolves—adding capacity as molecules advance and contracting as programs sunset.
Outcome. Fully outsourced PV operations under senior oversight, sized to the portfolio today and scaled to its trajectory.
AI-enabled PV
AI-enabled tools can reduce repetitive effort in intake, extraction, triage, quality review, and workflow routing. Isthmus uses them only where they can be implemented with appropriate human oversight, validation planning, auditability, privacy controls, and clear sponsor accountability.
AVAILABLE NOW
Through technology partnerships, Isthmus can support AI-enabled adverse event intake and mailbox triage workflows, including controlled case capture, structured field extraction, and initial routing.
Implementation is treated as a controlled component of the sponsor’s PV system, with human review, documented decision points, validation planning, audit trails, privacy considerations, and integration pathways assessed against the existing safety technology environment.
HUMAN-IN-THE-LOOP
Automation may draft, extract, suggest, or route; trained human reviewers remain responsible for medical judgment, coding confirmation, reportability, narrative quality, and submission approval.
The principal
FOUNDER · PRACTICE PRINCIPAL
Junaid Memon is a global pharmacovigilance executive with sixteen years of leadership across PV operations, safety governance, lifecycle safety management, benefit-risk oversight, regulatory compliance, and safety-systems transformation.
His experience spans small biotechnology companies, clinical-stage and mid-size pharma organizations, and larger pharma operating environments. He builds and transforms PV functions by translating regulatory expectations into practical operating models, vendor frameworks, procedures, safety systems, reconciliation controls, and inspection-ready governance.
His advisory approach is stage-based rather than template-driven: decide what must be built now, what can be outsourced, what can reasonably wait, and what must be demonstrably controlled before the next milestone.
He has led global PV operations through NDA, MAA, and BLA submission activity, commercial drug-device combination product launches, safety database and vendor transitions, and PV inspection settings involving FDA, MHRA, DKMA, and EU GVP expectations, including inspections without critical findings.
He also advises early-stage technology developers building AI-enabled pharmacovigilance capabilities, with a focus on human-in-the-loop design, operational control, and sponsor-visible accountability.
He holds an MBA in Strategic Management from Pace University, an MBA in Healthcare Management from Goldey-Beacom College, and a medical degree from C.M.P. Homoeopathic Medical College, Mumbai.
Small biotech · Mid-size pharma · Larger pharma operating environments
Pre-IND · First-in-human · Pivotal · Submission · Launch · Post-marketing
FDA · MHRA · DKMA · EU GVP inspection settings
Stage-appropriate PV infrastructure · Vendor oversight · Safety systems · Inspection readiness
Begin a conversation
A first conversation is practical and confidential: where the sponsor is now, what milestone is approaching, what safety infrastructure already exists, and what needs to be strengthened before the next decision point.
Schedule a conversationIndia, anchored in Mumbai
US relationship presence · San Jose